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Ulcerative ColitisPhase 2NCT06213857

Beneficial Effect of Silymarin in Ulcerative Colitis

A Phase 2 study testing Silymarin, Mesalamine and Azathioprine in people with Ulcerative Colitis, run by Tanta University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Silymarin, Mesalamine and Azathioprine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesEgypt
Study dates
1 Feb 2025to Jun 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults of both sexes aged from 18 years to 65 years.
  • Adults with normal kidney and liver functions.
  • Patients who sign the consent and willing to participate in the study.
  • Patients with UC according to American College of Gastroenterology Clinical Guidelines for diagnosis Ulcerative Colitis having clinical signs and symptoms with a completed medical workup, colonoscopy, pathological and laboratory data confirming UC

Who cannot join

  • Previous hypersensitivity or anaphylactic reaction to silymarin.
  • Significant renal and hepatic impairment.
  • Patients who refuse to participate.
  • Pregnant women, breastfeeding women and smokers.
  • Patients taking corticosteroids or biological therapy.
  • Patients taking any other antioxidants.
  • Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmad A Ahmad Eltayeb, Cl.Ph contact

+201140399467

PG_165473@pharm.tanta.edu.eg

Dalia R Mohammed ElAfify, Asst.Prof contact

+201006831093

dalia.mohamed1@pharm.tanta.edu.eg

Egypt2 sites, 2 recruiting
  • Mabarra Hospital

    Asyut, 71511

    Recruiting
  • Rajhy Hospital

    Asyut, 71511

    Recruiting

Other trials in Egypt

About this study

Official title: Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians.

Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups:

Read more
  • Group Ⅰ (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months.
  • Group Ⅱ (Silymarin group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140 mg/day) for 3 months.

The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.

Read the detailed description

Inflammatory Bowel Disease (IBD), is a debilitating progressive chronic inflammatory disorder of the small intestine and colon characterized by alternative phases of clinical relapse and remission. IBD includes two types, Crohn's Disease (CD) and Ulcerative Colitis (UC), CD can affect any part of the gastrointestinal tract, whereas UC involves only rectum and colon.

UC is a chronic idiopathic inflammatory disease characterized by relapsing and remitting mucosal inflammation involving the colon and the rectum. The peak age of disease onset is between ages 30 years and 40 years. Although the exact etiology of UC remains uncertain, a combination of patient's immune response, genetics, microbiome, and environment plays an important role in the development of the inflammation. The incidence of UC is similarly in men and women, but varies with ethnicity. UC has the highest incidence in the USA, UK and Sweden. In Egypt, the prevalence is low, but newly diagnosed cases are increasing rapidly.

The most common signs and symptoms of UC include bloody stool, diarrhea, vomiting, fatigue, abdominal pain, fever, weight loss with enhanced risk of colorectal cancer and several extra intestinal manifestations (e.g., arthritis, uveitis, and skin disease). Symptoms are often non-specific, and patients frequently suffer from long-lasting subclinical disease activity that is difficult to monitor and treat.

A chronic uncontrolled immune response is the net result of excessive immune activity of effector lymphocytes with increased production of pro-inflammatory cytokines, while regulatory immune cells and mediators fail to maintain tissue homeostasis. Chronically active inflammation is directly coupled to the generation and release by immune cells of reactive oxygen species (ROS), serving as important signaling molecules that contribute to their immunological functions. The continuous release of ROS in the local microenvironment of actively inflamed mucosal lesions causes extensive cellular and molecular damage, leading to intestinal inflammation and increased tissue destruction.

Oxidative stress which is an imbalance between ROS and antioxidant activity as the result of either ROS overproduction or a decreased antioxidant activity, has been proposed as one of the major mechanism involved in the pathophysiology of UC. Once the free radicals are formed, this reactive species begins to interact with the molecular complexes causing cellular oxidative damage. Under physiological conditions, their generation is controlled by the antioxidant system, which consists of enzymes such as superoxide dismutase (SOD), catalase, and glutathione peroxidase (GPX).

Increased ROS have destructive effects which can affect lipids, proteins, and nucleic acids that causes lipid peroxidation, enzymatic dysfunction, and DNA strand break products. These destructive effects can be removed by antioxidant balance, which acts like free radical scavengers or cellular oxidation inhibitors. The main cellular antioxidant enzymes involved in the inhibition are catalase, SOD, and GPX. Activated neutrophils and macrophages are responsible for ROS generation, and their levels can be correlated with the severity of inflammation. It has been shown that IL 1 and TNFα cytokines can be inhibited by antioxidants administered to patients with UlcerativeColitis.

The American College of Gastroenterology (ACG) recommends performing a complete blood count (CBC), and measuring inflammatory markers such as c-reactive protein (CRP), erythrocyte sedimentation rate (ESR). It also recommends measuring Liver transaminases (aspartate and alanine aminotransferase). Measurement of fecal calprotectin is useful for screening intestinal inflammation associated with disease activity.

Silymarin (milk thistle), an extract obtained from Silybum marianum seeds, is one of these natural sources containing a complex of flavonolignans with a potent intracellular antioxidant property. The first usage of Milk thistle was for its hepatoprotective and antioxidant activities, but in the recent years its benefit has been reported in control of immune based murine colitis by healing of bowel histology and reduction of bowel inflammatory cytokines especially TNF-α, interleukin-1β (IL-1β), and nuclear factor κB (NF-κB). Silymarin has numerous health benefits and exerts its effects via various molecular mechanisms. Silymarin has anti-viral, immunomodulation, anti-inflammatory effects as well as antioxidant properties by scavenging free radicals and increasing the glutathione concentrations, anti-arthritis, antidiabetic, protective and wound healing effects.

Being tested
Silymarin, Mesalamine, Azathioprine
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SilymarinDietary supplement

    Also called Milk Thistle

    Silymarin (milk thistle), an extract obtained from Silybum marianum seeds containing a complex of flavonolignans with a potent intracellular antioxidant property. The first usage of Milk thistle was for its hepatoprotective and antioxidant activities, but in the recent years it has been used to control of immune based murine colitis by healing of bowel histology and reduction of bowel inflammatory cytokines especially TNF-α, interleukin-1β (IL-1β), and nuclear factor κB (NF-κB). Silymarin has anti-viral, immunomodulation, anti-inflammatory effects as well as antioxidant properties by scavenging free radicals and increasing the glutathione concentrations, protective and wound healing effects. It increases the gene expression of antioxidant enzymes and the number of the most important protection mechanisms against free-radicals damage containing superoxide dismutase (SOD), glutathione peroxidase (GPX), and catalase.

  • MesalamineDrug

    Also called Mesalazine

    A 5-aminosalicylic acid compound used in the treatment of mild to moderate ulcerative colitis, with high rates of efficacy in induction and maintenance of remission.

  • AzathioprineDrug

    Also called Immuran

    An immunosuppressive medication that is used for the treatment of inflammatory bowel disease (Crohn's disease and ulcerative colitis). It works by decreasing the activity of the body's immune system so it will not attack itself.

Study groups in NCT06213857
Study groupRoleWhat they receive
A (Control group)Active comparatorMesalamine (2g/day) + Azathioprine (50mg/day) for 3 months
Receives: Drug: Mesalamine; Drug: Azathioprine
B (Silymarin group)ExperimentalMesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140mg/day) for 3 months
Receives: Dietary Supplement: Silymarin; Drug: Mesalamine; Drug: Azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 points or more decrease in the Mayo score from baseline

    The Mayo score is one of the most commonly used disease activity indices in controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance. Each part is rated from 0 to 3, giving a total score of 0 to 12. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease.

    Measured: baseline, 3 months

Secondary outcomes (3)
  1. The change in the level of fecal calprotectin

    Significant decrease in the marker level

    Measured: baseline, 3 months

  2. The change in the level of superoxide dismutase

    Significant decrease in the marker level

    Measured: baseline, 3 months

  3. The change in the level of TNF-α.

    Significant decrease in the marker level

    Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start1 Feb 2025
  3. Primary completionMay 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized parallel study that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: * Group Ⅰ (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months. * Group Ⅱ (Silymarin group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50 mg/day) + Silymarin (140 mg/day) for 3 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213857
Sponsor's protocol ID
Silymarin in UC
Status last verified
Mar 2025
First submitted
9 Jan 2024
Last updated
5 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Silymarin, Mesalamine and Azathioprine in people with Ulcerative Colitis, run by Tanta University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmad A Ahmad Eltayeb, Cl.Ph (+201140399467, PG_165473@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 points or more decrease in the Mayo score from baseline (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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